Efficacy Study of Vitamin D to Treat Contrast-induced Nephropathy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02489240

Enrollment

306

Registered

2015-07-02

Start date

2015-07-31

Completion date

2017-07-31

Last updated

2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-induced Nephropathy

Brief summary

The investigators planned to research the effect of vitamin D supplementation on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography.

Detailed description

Vitamin D is primarily generated in the skin, in response to direct absorption of ultraviolet B radiation. Vitamin D can also be obtained through fortified foods and oral supplements. Contrast-induced nephropathy (CIN) is a generally reversible form of acute kidney injury that occurs mostly within 2-3 days of exposure to contrast medium (CM). The estimated incidence of CIN ranges from 2%-50%, and coronary angiography (CAG) or percutaneous coronary intervention (PCI), or both, are associated with CIN in about half of cases. Recently low vitamin D status has been shown to be associated with increased risk of CIN. However, its effects on CIN patients remain unclear. The investigators planned to determine the efficacy of vitamin D on the incidence of contrast-induced nephropathy in patients undergoing coronary angiography. This study may shed light as to whether oral vitamin D supplementation can be an adjunct therapy in CIN patients.

Interventions

DRUGvitamin D3 tablets

2000 IU vitamin D3 tablets were taken daily for 6 days

DRUGplacebo

2000 IU placebo tablets were taken daily for 6 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* The main inclusion criteria were patients who underwent coronary angiography.

Exclusion criteria

* The

Design outcomes

Primary

Measure	Time frame	Description
the prevalence of contrast-induced nephropathy	48-72h after treatment	The primary efficacy variable was the prevalence of CIN between the vitamin D group and the control group.

Secondary

Measure	Time frame	Description
a change in serum creatinine level	at 1, 2, 3 days after percutaneous coronary intervention	The change in serum creatinine level was measured at 1, 2, 3 days after the procedure.

Other

Measure	Time frame	Description
differences in the incidences of treatment-emergent adverse events	6 days after treatment	Treatment-emergent adverse events (TEAEs): hypercalcemia, renal insufficiency, constipation

Countries

China

Contacts

Primary ContactYang Shi, M.D.

ggyyong@sina.com+8610-66876231

Backup Contacthao wang, M.D.